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Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis

Not Applicable
Completed
Conditions
Chronic Pain
Osteo Arthritis Knee
Interventions
Device: transcranial direct current stimulation (tDCS)
Device: TENS
Behavioral: Exercise and General Education
Registration Number
NCT05138471
Lead Sponsor
Universidad de Murcia
Brief Summary

Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.

Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
65
Inclusion Criteria
  • Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
  • Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
  • Pain in Analog Visual Scale more than 4/10
  • Matutinal less than 30 minutes
  • Absence of hyperthermia upon palpation in the joint
  • Alteration of the bone image
  • Crepitus
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Exclusion Criteria
  • Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
  • Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
  • Patients who have undergone knee replacement surgery on the contralateral knee.
  • Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
  • Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
  • Patients who decline to participate out of fear or denial of therapy.
  • Severe heart disease that prevent exercise.
  • Body Mass Index above 45.
  • Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
  • Patients with metallic implants in the area (skull or knee).
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
tDCS Active vs TENS Activetranscranial direct current stimulation (tDCS)-
tDCS Active vs TENS ActiveTENS-
tDCS Active vs TENS ActiveExercise and General Education-
tDCS Active vs TENS Placebotranscranial direct current stimulation (tDCS)-
tDCS Active vs TENS PlaceboExercise and General Education-
tDCS Placebo vs TENS PlaceboExercise and General Education-
Primary Outcome Measures
NameTimeMethod
Chronic Knee PainThrough study completion, an average of 1 year.

The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).

Secondary Outcome Measures
NameTimeMethod
Coordination and BalanceThrough study completion, an average of 1 year.

Timed Up and Go Test (TUG), less than 10 seconds (low risk of falls) more than 20 seconds (high risk of falls).

Function and Quality of LifeThrough study completion, an average of 1 year.

The Western Ontario and McMaster (WOMAC) scale will be used to assess pain, function, and quality of life in knee osteoarthritis and range from 0 to 96 (higher score, worst outcome).

ForceThrough study completion, an average of 1 year.

Using a dynamometer for quadriceps muscle (measurement in Kg, higher score means better outcome).

BalanceThrough study completion, an average of 1 year.

A short physical performance battery (SPPB) will be used to measure balance. SPPB ranges from 0 (worst) to 12 (best).

Gait properties.Through study completion, an average of 1 year.

6 Minutes Walk Test (meters) measure exercise tolerance, less than 350 meters is high risk of death in some patients. More meters, more score.

Central SensitizationThrough study completion, an average of 1 year.

8Central Sensitization Inventory (CSI) range from 0 to 100 (higher values are worst outcome)

KinesiophobiaThrough study completion, an average of 1 year.

The Tampa Scale of Kinesiophobia (TSK) range from 11 to 44 (higher values are worst outcome).

UncertainlyThrough study completion, an average of 1 year.

Mishel's Uncertainly Scale (MUIS) range from 55 to 121 (more score, greater uncertainly, worst outcome).

CatastrophizingThrough study completion, an average of 1 year.

The Pain Catastrophizing Scale (PCS) range from 0 to 52 (more score, greater catastrophizing, worst outcome).

Trial Locations

Locations (1)

University of Murcia

🇪🇸

Murcia, Spain

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